In Australia, Revlimid (lenalidomide) has received marketing authorization approval from the Australian Therapeutic Goods Administration (TGA) for use in combination with dexamethasone as a treatment for patients with multiple myeloma (MM) whose disease has progressed after one therapy.
In Canada, Revlimid received conditional marketing authorization approval from the Canadian Therapeutic Products Directorate (TPD) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
In the EU, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the company’s marketing authorization application (MAA) for lenalidomide – Celgene Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Based on information available to the CHMP from the uncontrolled, open-label, 148-patient Phase II study (MDS-003), the CHMP was not convinced the data were sufficient to assure safety. Celgene intends to apply for a re-examination of the CHMP Opinion in accordance with relevant EMEA procedures.